35 U.S.C. §112 : CAFC Alert

CLAIMS ARE VIEWED AND UNDERSTOOD IN THE CONTEXT OF THE SPECIFICATION AND THE PROSECUTION HISTORY

| March 7, 2022

Nature Simulation Systems Inc., v. Autodesk, Inc.

Before NEWMAN, LOURIE, and DYK, Circuit Judges. Opinion for the court filed by Circuit Judge NEWMAN. Dissenting opinion filed by Circuit Judge DYK.

Summary

      The Federal Circuit ruled in a split decision that the United States District Court for the Northern District of California erred in invalidating Nature Simulation System’s patents as indefinite.  

Background

      NSS sued Autodesk for allegedly infringing US Patents No. 10,120,961 (“the ’961 patent”) and No. 10,109,105 (“the ’105 patent”). The ’961 patent is a continuation-in-part of the ’105 patent, and both are entitled “Method for Immediate Boolean Operations Using Geometric Facets” directed to a computer-implemented method for building three-dimensional geometric objects using boolean operation.

      The district court held a claim construction (Markman) hearing and subsequently ruled the claims invalid on the ground of claim indefiniteness, 35 U.S.C. § 112(b).  In the hearing, Autodesk presented an expert declaration to request the construction of eight claim terms. NSS argued that construction is not necessary and the challenged terms should receive their ordinary meaning in the field of technology. The district court did not construe the terms. The district court explained that a claim term is indefinite, as a matter of law, if there are any “unanswered questions” about the term. The decision of the district court was based on two of the challenged terms in clauses [2] and [3] of Claim 1:

1. A method that performs immediate Boolean operations using geometric facets of geometric objects
implemented in a computer system and operating with a computer, the method comprising:
[1] mapping rendering facets to extended triangles that contain neighbors;
[2] building intersection lines starting with and ending with searching for the first pair of triangles that hold a start point of an intersection line by detecting whether two minimum bounding boxes overlap and performing edge-triangle intersection calculations for locating an intersection point, then searching neighboring triangles of the last triangle pair that holds the last intersection point to extend the intersection line until the first intersection point is identical to the last intersection point of the intersection line ensuring that the intersection line gets closed or until all triangles are traversed;
[3] splitting each triangle through which an intersection line passes using modified Watson method, wherein the modified Watson method includes removing duplicate intersection points, identifying positions of end intersection points, and splitting portion of each triangle including an upper portion, a lower portion, and a middle portion;
[4] checking each triangle whether it is obscure or visible for Boolean operations or for surface trimming;
[5] regrouping facets in separate steps that includes copying triangles, deleting triangles, reversing the normal of each triangle of a geometric object, and merging reserved triangles to form one or more new extended triangle sets; and
[6] mapping extended triangles to rendering facets.

      The two terms are “searching neighboring triangles of the last triangle pair that holds the last intersection point” and “modified Watson method.” The district court stated that even if the questions are answered in the specification, the definiteness requirement is not met if the questions are not answered in the claims. NSS argued that on the correct law the claims are not indefinite.

Discussion

      The Federal Circuit cited the opinion in Nautilus and emphasized that the claims are viewed and understood in the context of the specification and the prosecution history, as the Court summarized in Nautilus (Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 909 (2014) ).

      The district court held the claims indefinite based on the “unanswered questions” that were suggested by Autodesk’s expert, as stated in the Declaration:

¶ 27. [T]he claim language, standing alone, does not specify which of those neighboring, intersecting triangles should be used to identify additional intersection points. Nor does the claim specify (where there are multiple potential intersection points for a given pair of neighboring triangles) which of the multiple potential intersection points should be used to extend the intersection line. Thus, the claim language is indefinite.

      The Federal Circuit states that the “unanswered questions” is an incorrect standard and specifically pointed out that “ ‘Claim language, standing alone’ is not the correct standard of law, and is contrary to uniform precedent.” The Federal Circuit found that the district court did not consider the information in the specification that was not included in the claims and the district court misperceived the function of patent claims.

      The Federal Circuit also noted that the court did not discuss the Examiner’s Amendment. During the prosecution of the ‘961 patent, the examiner discussed with the inventor and later suggested an amendment in the Notice Of Allowance to clarify the disputed language. The examiner suggested amending claim 1 and then withdrew the rejection based on the amendment. The amendment includes the limitation of the term in  clause [3] as follows:

[3] splitting each triangle through which an intersection line passes using modified Watson method, wherein the modified Watson method includes removing duplicate intersection points, identifying positions of end intersection points, and splitting portion of each triangle including an upper portion, a lower portion, and a middle portion;

      The Federal Circuit noted that the district court did not discuss the Examiner’s Amendment and held that the claims are invalid since the questions raised by Autodesk’s expert were not answered. The Federal Circuit found that the district court fails to give proper weight to the prosecution history showing the resolution of indefiniteness by adding the designated technologic limitations to the claims. The Federal Circuit further explained that “[a]ctions by PTO examiners are entitled to appropriate deference as official agency actions, for the examiners are deemed to be experienced in the relevant technology as well as the statutory requirements for patentability.” The Federal Circuit stated that “[i]t is not disputed that the specification describes and enables practice of the claimed method, including the best mode. The claims, as amended during prosecution, were held by the examiner to distinguish the claimed method from the prior art and to define the scope of the patented subject matter.”

      Judge Dyk dissented from the majority and opined that the district court had read the patent claims in light of the specification to determine if it would inform those skilled in the art about the scope of the invention with reasonable certainty, which is exactly what is required under Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 910 (2014). Judge Dyk also states that the majority simply does not address the problem that the limitations are “not describe[d]” in the patent, “ambiguous” and “unclear,” and “inconsistent with” Figure 13 and the accompanying text. In his view, the test for definiteness is whether the claims “inform those skilled in the art about the scope of the invention with reasonable certainty,” but the majority relied on the fact that these limitations were suggested by the patent examiner.

Takeaway

  • Claims are viewed and understood in the context of the specification and the prosecution history.
  • Patent claims must provide sufficient clarity to inform about the scope of the invention with reasonable certainty.

Definitely Consisting Essentially Of: Basic and Novel Properties Must Be Definite Under 35 U.S.C. §112

| November 15, 2019

HZNP Medicines, LLC, Horizon Pharma USA, Inc. v. Actavis Laboratories UT, Inc.

October 15, 2019

Before: Prost, Reyna and Newman; Opinion by:  Reyna; Dissent-in-part by:  Newman

Summary:  Horizon appealed a claim construction that the term “consisting essentially of” was indefinite. The district court evaluated the basic and novel properties under the Nautilus definiteness standard and found that the properties set forth in Horizon’s specification where indefinite. Horizon maintained this was legal error.  The CAFC found that having used the phrase “consisting essentially of,” Horizon thereby incorporated unlisted ingredients or steps that do not materially affect the basic and novel properties of the invention.  They asserted that a drafter cannot later escape the definiteness requirement by arguing that the basic and novel properties of the invention are in the specification, not the claims.  Newman dissents, noting that no precedent has held that “consisting essentially of” composition claims are invalid unless they include the properties of the composition in the claims and that the majority’s ruling “sows conflict and confusion.”

Details: 

  1. Background

HZNP Medicines, LLC, Horizon Pharma USA, Inc (“Horizon”) owns a series of patents directed to a methods and compositions for treating osteoarthritis.  Actavis Laboratories UT, Inc (“Actavis”) sought to manufacture a generic version.  Horizon sued Actavis for infringement in the District of New Jersey.  Most of Horizon’s claims were removed by Summary Judgment on multiple issues.  One claim survived to trial and was found valid and infringed.  The CAFC taking up the appeal and cross-appeal on a number of issues (induced infringement, obviousness of a modified chemical formula and indefiniteness) affirmed the District Court. 

This paper focuses on the ruling that Horizon claims using the “consisting essentially of” transitional phrase where invalid based on the basic and novel properties being indefinite under 35 U.S.C. §112.

  • The CAFC’s Decision

Several of the claims in the Horizon patents recited  a formulation “consisting essentially of” various ingredients.  Claim 49 of the ’838 patent was used as the example.

49. A topical formulation consisting essentially of:

1–2% w/w diclofenac sodium;

40–50% w/w DMSO;

23–29% w/w ethanol;

10–12% w/w propylene glycol;

hydroxypropyl cellulose; and

water to make 100% w/w, wherein the topical formulation has a viscosity of 500–5000 centipoise.

The claims had been found invalid by the District Court under Summary Judgement following a Markman hearing.  The parties’ dispute focused on the basic and novel properties of the claims.  The CAFC agreed with the District Court that these properties are implicated by virtue of the phrase “consisting essentially of,” which allows unlisted ingredients to be added to the formulation so long as they do not materially affect the basic and novel properties.

The district court held that the specification of the patents identified five basic and novel properties: (1) better drying time; (2) higher viscosity; (3) increased transdermal flux; (4) greater pharmacokinetic absorption; and (5) favorable stability.  Further, the district court reviewed the characteristics and found that at least “better drying time” was indefinite because the specifications provided two separate manners of determining drying time which were inconsistent.  Based thereon, they concluded that the basic and novel properties of the claimed invention were indefinite under Nautilus

The CAFC evaluated whether the Nautilus definiteness standard applies to the basic and novel properties of an invention.  Horizon had argued that the Nautilus definiteness standard focuses on the claims and therefore does not apply to the basic and novel properties of the invention. The majority found this argument to be “misguided” and asserted that by using the phrase “consisting essentially of” in the claims, the inventor in this case incorporated into the scope of the claims an evaluation of the basic and novel properties.

The use of “consisting essentially of” implicates not only the items listed after the phrase, but also those steps (in a process claim) or ingredients (in a composition claim) that do not materially affect the basic and novel properties of the invention. Having used the phrase “consisting essentially of,” and thereby incorporated unlisted ingredients or steps that do not materially affect the basic and novel properties of the invention, a drafter cannot later escape the definiteness requirement by arguing that the basic and novel properties of the invention are in the specification, not the claims.

They supported this position by noting that a patentee can reap the benefit of claiming unnamed ingredients and steps by employing the phrase “consisting essentially of” so long as the basic and novel properties of the invention are definite.

In evaluating the district courts finding of indefiniteness, the CAFC maintained that two questions arise when claims use the phrase “consisting essentially of.” The first focusing on definiteness: “what are the basic and novel properties of the invention?”  The second, focusing on infringement: “does a particular unlisted ingredient materially affect those basic and novel properties?”   The definiteness inquiry focuses on whether a person of ordinary skill in the art (“POSITA”) is reasonably certain about the scope of the invention.  If the POSITA cannot as-certain the bounds of the basic and novel properties of the invention, then there is no basis upon which to ground the analysis of whether an unlisted ingredient has a material effect on the basic and novel properties.  Keeping with this logic, the CAFC maintained that to determine if an unlisted ingredient materially alters the basic and novel properties of an invention, the Nautilus definiteness standard requires that the basic and novel properties be known and definite.

Hence, the CAFC concluded that the district court did not err in considering the definiteness of the basic and novel properties during claim construction.

The majority then looked to the specific finding of indefiniteness by the district court regarding the basic and novel property of “better drying time.”   They noted that the  specification discloses results from two tests: an in vivo test and an in vitro test.  The district court had found that the two different methods for evaluating “better drying time” do not provide consistent results at consistent times. Accordingly, CAFC affirmed the district court’s conclusion that the basic and novel property of “better drying rate” was indefinite, and consequently, that the term “consisting essentially of” was likewise indefinite.

In sum, we hold that the district court did not err in: (a) defining the basic and novel properties of the formulation patents; (b) applying the Nautilus definiteness standard to the basic and novel properties of the formulation patents; and (c) concluding that the phrase “consisting essentially of” was indefinite based on its finding that the basic and novel property of “better drying time” was indefinite on this record.

However, they noted that the Nautilus standard was not to be applied in an overly stringent manner.

To be clear, we do not hold today that so long as there is any ambiguity in the patent’s description of the basic and novel properties of its invention, no matter how marginal, the phrase “consisting essentially of” would be considered indefinite. Nor are we requiring that the patent owner draft claims to an untenable level of specificity. We conclude only that, on these particular facts, the district court did not err in determining that the phrase “consisting essentially of” was indefinite in light of the indefinite scope of the invention’s basic and novel property of a “better drying time.”

Judge Newman’s Dissent

Judge Newman dissented.  She asserted that the majority holding that “By using the phrase ‘consisting essentially of’ in the claims, the inventor in this case incorporated into the scope of the claims an evaluation of the basic and novel properties”  is not correct as a matter of claim construction, it is not the law of patenting novel compositions, and it is not the correct application of section 112(b).

First, she noted that there is no precedent that when the properties of a composition are described in the specification, the usage “consisting essentially of” the ingredients of the composition invalidates the claims when the properties are not repeated in the claims.

            Second, in regard to the specifics of “drying time” for the case at hand, she noted that whatever the significance of drying time as an advantage of the claimed composition, recitation and measurement of this property in the specification does not convert the composition claims into invalidating indefiniteness because the ingredients are listed in the claims as “consisting essentially of.”

The role of the claims is to state the subject matter for which patent rights are sought.  The usage “consisting essentially of” states the essential ingredients of the claimed composition. There are no fuzzy concepts, no ambiguous usages in the listed ingredients. There is no issue in this case of the effect of other ingredients…

Noting that there was no evidence that a POSITA would not understand the components of the composition claims with reasonable certainty, Newman concluded that since in the current case there are no other components asserted to be present, no “unnamed ingredients and steps” that even adopting the construction taken by the majority the claims are not subject to invalidity for indefiniteness.

Takeaways: 

            Added caution must be taken by patent prosecutors when electing to use the transitional phrase “consisting essentially of”.  The specification needs to be clear as to what the basic and novel properties are and how they are determinable. 

            When using “consisting essentially of” incorporating the properties that are considered to be basic and novel into the claim language may help prevent ambiguity.

A Patent of Few Words and a Defendant with a Few Parts cannot avoid a Trier of Fact

| February 22, 2019

Centrak, Inc. v. Sonitor Tech., Inc.

February 14, 2019

Before Reyna, Taranto and Chen.  Opinion by Chen.

Summary:      

The CAFC reversed and remanded a Motion of Summary Judgment finding that the District Court errored in focusing on the length of a written description and dismissing a plausible theory for direct infringement based on the final assembly being done by the defendant within a customer’s system.

Details

  1. Background

CenTrak, Inc. sued Sonitor Technologies, Inc. for alleged infringement of U.S. Patent No. 8,604,909 (’909 patent), which claims systems for locating and identifying portable devices using ultrasonic base stations. The district court granted Sonitor’s MSJ that the relevant claims   are invalid for lack of written description and are not directly infringed because Sonitor does not individually provide for all the aspects of the claims.

The claims are directed to ultrasonic base stations which can be mounted in various fixed locations in a facility, such as rooms in a hospital, and the portable devices can be attached to people or assets that move between rooms. Each portable device is configured to detect the ultrasonic location codes from the nearby ultrasonic base stations and “transmit an output signal including a portable device ID representative of the portable device and the detected ultrasonic location code.” While the portable devices receive location codes from ultrasonic base stations via ultrasound, they might transmit location and device information via RF to an RF base station.

The asserted claims generally recite: (1) ultrasonic (US) base stations; (2) portable devices (tags); (3) a server; (4) radio frequency (RF) base stations; and (5) a backbone network that connects the server with the RF base stations.

All the claims of the ’909 patent are directed to “ultrasonic” components.  However, the specification focuses on infrared (IR) or RF components. Only two sentences of the ’909 patent’s specification discuss ultrasonic technology:

Although IR base stations 106 are described, it is contemplated that the base stations 106 may also be configured to transmit a corresponding BS-ID by an ultrasonic signal, such that base stations 106 may represent ultrasonic base stations. Accordingly, portable devices 108 may be configured to include an ultrasonic receiver to receive the BS-ID from an ultrasonic base station.

In regard to lack of written description, Sonitor argued that the two sentences in the specification dedicated to ultrasound, did not show that the inventors had possession of an ultrasound-based RTL system.

Regarding invalidity, the district court ruled that while the specification “contemplated” ultrasound, “[m]ere contemplation . . . is not sufficient to meet the written description requirement.

In regard to infringement, the accused Sonitor Sense system includes three pieces of hardware sold by Sonitor: RF “gateways,” ultrasonic location transmitters, and portable locator tags. Sonitor also provides software for installation on a customer’s server hardware.

Sonitor’s main non-infringement argument was that Sonitor does not make, use, or sell certain elements recited in the claims, including the required backbone network, Wi-Fi access points, or server hardware.

CenTrak argues that the resulting system infringes the ’909 patent when the components Sonitor sells are integrated with a customer’s existing network and server hardware. CenTrak asserted only direct infringement.  Since, Sonitor does not sell all of the hardware necessary to practice the asserted claims, so, on appeal, CenTrak only pursued a theory under 35 U.S.C. § 271(a) that Sonitor “makes” infringing systems when it installs and configures the Sonitor Sense system.  In short, the crux of CenTrak’s assertion is that there is direct infringement when the party assembles components into the claimed assembly (i.e. the party “makes” the patented invention, even when someone else supplies most of the components).

The district court granted summary judgment of non-infringement.  It held that a defendant must be the actor who assembles the entire claimed system to be liable for direct infringement, and CenTrak had not submitted proof that Sonitor personnel had made an infringing assembly.

CenTrak appealed both MSJ grants.

  2. Opinion

In regard to invalidity, the CAFC held that, the district court leaned too heavily on the fact that the specification devoted relatively less attention to the ultra-sonic embodiment compared to the infrared embodiment.  Quoting their ScriptPro LLC v. Innovation Associates, Inc., 833 F.3d 1336, 1341 (Fed. Cir. 2016), they reiterated that “a specification’s focus on one particular embodiment or purpose cannot limit the described invention where that specification expressly contemplates other embodiments or purposes.”

The Court explained that the real question is the level of detail the ’909 patent’s specification must contain, beyond disclosing that ultrasonic signals can be used, to adequately convey to a skilled artisan that the inventors possessed an ultrasonic embodiment.  Citing their Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) en banc: “the level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.”  They further noted per Ariad that the issue of whether a claimed invention satisfies the written description requirement is a question of fact.

The opinion details that the parties disputed the complexity and predictability of ultrasonic RTL systems, and the district court erred at the summary judgment stage by not sufficiently crediting testimony from CenTrak’s expert that the differences between IR and ultrasound, when used to transmit small amounts of data over short distances, are incidental to carrying out the claimed invention.  The Court specifically noted the testimony from CenTrak’s expert that those details were not particularly complex or unpredictable, and Sonitor does not explain why a person of ordinary skill in the art would need to see such details in the specification to find that the named inventors actually invented the claimed system.

Hence, the Court concluded that:


…there is a material dispute of fact as to whether the named inventors actually possessed an ultrasonic RTL system at the time they filed their patent application or whether they were “leaving it to the . . . industry to complete an unfinished invention.”…


Here, as in ScriptPro, the fact that the bulk of the specification discusses a system with infrared components does not necessarily mean that the inventors did not also constructively reduce to practice a system with ultrasonic components … “the written description requirement does not demand either examples or an actual reduction to practice; a constructive reduction to practice” may be sufficient if it “identifies the claimed invention” and does so “in a definite way.” Ariad, 598 F.3d at 1352.

In regard to direct infringement, the Court noted that it is undisputed that Sonitor does not provide certain claimed elements in the accused systems, such as a backbone network, Wi-Fi access points, or server hardware.  Moreover, the district court analyzed the evidence CenTrak offered and concluded that no reasonable jury could find that Sonitor “made” the claimed invention by performing installations relying on Centillion Data Systems, LLC v. Qwest Communications International, Inc., 631 F.3d 1279 (Fed. Cir. 2011) for the proposition that to “make” a system, a single entity must assemble the entire system itself.

The CAFC found that Centillion does not rule out CenTrak’s infringement theory. In this case, Cen-Trak argued that the final, missing elements are the configuration that allows the location transmitters to work with the network and the location codes that are entered into the Sonitor server.  According to CenTrak, admissible evidence that Sonitor is the “final assembler” raises a triable issue of fact on infringement even though Sonitor does not “make” each of the claimed components of the accused systems.

The Court further held that under Lifetime Industries, Inc. v. Trim-Lok, Inc., 869 F.3d 1372 (Fed. Cir. 2017),  and Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1311 (Fed. Cir. 2005), a final assembler can be liable for making an infringing combination—assuming the evidence supports such a finding—even if it does not make each individual component element.

  3. Decision

The CAFC found that the District Court errored in both: (1) finding a lack of written description as it relied too heavily on the briefness of the ‘909 patents comments on ultrasonic RTL systems rather than the amount of knowledge needed for a skilled artisan to consider; and (2) finding that there was no dispute of fact as to whether Sonitor was a “final assembler” by virtue of performing the final system installation for its customers.  The Court therefore reversed and remanded.

Take away

  • The measure of a sufficient written description is not in its length.  Rather, the test is to the amount of disclosure necessary for a skilled artisan to discern that the inventor in fact possessed the invention.
  • A case for direct infringement can be made even where the defendant does not “make all the parts” if there is sufficient evidence that the accused infringer is a “final assembler” in terms of actuating the combination of elements to infringe.

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